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Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis (Saturn-1)

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ClinicalTrials.gov Identifier: NCT04475432
Recruitment Status : Completed
First Posted : July 17, 2020
Last Update Posted : July 7, 2021
Sponsor:
Information provided by (Responsible Party):
Tarsus Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE July 14, 2020
First Posted Date  ICMJE July 17, 2020
Last Update Posted Date July 7, 2021
Actual Study Start Date  ICMJE September 9, 2020
Actual Primary Completion Date May 4, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2020)
The proportion of participants cured based on their collarette score [ Time Frame: 43 days ]
Cure is defined as the presence of no more than 2 collarettes on the upper eyelid
Original Primary Outcome Measures  ICMJE
 (submitted: July 16, 2020)
The proportion of participants cured based on their collarette score [ Time Frame: 43 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2020)
  • The proportion of participants with their Demodex mites eradicated [ Time Frame: 43 days ]
    Mite eradication is defined as a mite density of 0 mites per lash
  • The proportion of participants cured based on a composite of collarette score and erythema cure [ Time Frame: 43 days ]
    Cure is defined as the presence of no more than 2 collarettes and the absence of erythema (age normal) of the upper eyelid
Original Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2020)
  • The proportion of participants with their Demodex mites eradicated [ Time Frame: 43 days ]
  • The proportion of participants cured based on a composite of collarette score and erythema cure [ Time Frame: 43 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis
Official Title  ICMJE Randomized, Controlled, Multicenter, Double-Masked, Parallel, Phase 2b/3 Trial to Evaluate the Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis
Brief Summary The purpose of this study is to compare the safety and efficacy of TP-03, 0.25%, an eyedrop, to its vehicle control for the treatment of blepharitis due to Demodex, a microscopic mite frequently found in human hair follicles. The hypothesis for the study is the proportion of participants cured at Day 43 with treatment by TP-03, 0.25%, is greater than the proportion cured by treatment with its vehicle.
Detailed Description This Phase 2b/3 study is a randomized, controlled, multicenter, double-masked, parallel trial to compare the safety and efficacy of TP-03, 0.25%, to vehicle control for the treatment of Demodex blepharitis. The primary objective of the study is to assess the safety and efficacy of TP-03 compared to its vehicle from Day 1 to Day 43 in adult participants with mild to severe Demodex blepharitis. The primary efficacy endpoint will be cure based upon collarettes. Safety will be determined by assessing adverse effects related to the treatment as well as evaluating any changes in visual acuity, intraocular pressure, slit lamp biomicroscopy and dilated ophthalmoscopy findings.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Active arm: TP-03 0.25%

Control arm: Vehicle of TP-03

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Treatment assignment will be unknown to the study participant, investigators and site staff performing study assessments.
Primary Purpose: Treatment
Condition  ICMJE Blepharitis
Intervention  ICMJE
  • Drug: TP-03, 0.25%
    TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day
    Other Name: Lotilaner ophthalmic solution, 0.25%
  • Drug: TP-03 Vehicle
    Vehicle of TP-03 ophthalmic solution, administered twice a day
    Other Name: Inactive control
Study Arms  ICMJE
  • Experimental: Active
    TP-03, lotilaner ophthalmic solution, 0.25%, administered topically twice a day for approximately 43 days
    Intervention: Drug: TP-03, 0.25%
  • Placebo Comparator: Control
    Vehicle of TP-03 ophthalmic solution, administered topically twice a day for approximately 43 days
    Intervention: Drug: TP-03 Vehicle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 5, 2021)
421
Original Estimated Enrollment  ICMJE
 (submitted: July 16, 2020)
418
Actual Study Completion Date  ICMJE May 4, 2021
Actual Primary Completion Date May 4, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Be willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol
  • Meet all of the following criteria in at least one eye: Have more than 10 lashes with collarettes present on the upper lid; have at least mild erythema of the upper eyelid margin; have an average Demodex density, upper and lower eyelids combined, of 1.5 or more mites per lash

Exclusion Criteria:

  • Have used lid hygiene products within 14 days of Screening or unwilling to forego the use of lid hygiene products during the study
  • Have worn contact lenses within 7 days of Screening or be unwilling to forego contact lens wear during the study
  • Have used artificial eyelashes or eyelash extensions within 7 days of Screening or be unwilling to forego their use during the study
  • Pregnancy or lactation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04475432
Other Study ID Numbers  ICMJE TRS-009
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tarsus Pharmaceuticals, Inc.
Study Sponsor  ICMJE Tarsus Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Wirta, MD Eye Research Foundation
PRS Account Tarsus Pharmaceuticals, Inc.
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP